CN102858272B - Expansion device for treatment of vascular passageways - Google Patents

Abstract

A delivery system for delivering an expandable member to a treatment location includes an elongate shaft and an expandable member coupled to a distal end of the elongate shaft. The expandable member is moveable between a collapsed configuration and an expanded configuration, and has an inner expandable member and a plurality of outer expandable members that at least partially surround the inner expandable member.

Description

Expansion device for treatment of vascular passages

technical field

The present disclosure relates to devices and methods useful in the treatment of heart valve disorders, including balloon valvuloplasty and transcatheter heart valve delivery.

Background technique

Heart valve disease is a serious problem that involves the failure of one or more valves of the heart. This fault can manifest itself in various ways. For example, valvular stenosis is calcification or narrowing of the natural heart valves. As a result, the natural heart valve does not open fully and blood flow through the natural valve is blocked or restricted. Another example of heart valve disease is valvular insufficiency. Valvular insufficiency is the failure of the natural heart valves to close properly to prevent leakage or backflow of blood through the valves.

Various approaches have been developed to treat heart valve disease. Some of these methods require balloon elements that are inflated within the native heart valve. For example, balloon elements may be used in valvuloplasty procedures where the balloon element is positioned within a native heart valve and inflated to increase the opening size (ie, flow area) of the native heart valve and thereby improve blood flow. Another procedure that may be performed is valve replacement, in which the natural heart valve is replaced with an artificial heart valve. Implanting a prosthetic heart valve in the heart may also include expanding a balloon member in the valve annulus. For example, the balloon element can be used to increase the size of a natural valve before implanting a prosthetic valve and/or it can be used to inflate and expand the prosthetic valve itself.

However, inflation of the balloon element within the native valve or other vascular passageway can temporarily prevent or restrict blood flow through the passageway. Severe injury or death can occur if blood flow is blocked or restricted in the channel for too long. Also, in the case of valve replacement, placement of a prosthetic heart valve can be complicated by the buildup of pressure in the left ventricle. Accordingly, valvuloplasty and valve replacement procedures, and other similar procedures using inflatable balloon elements typically must be performed rapidly and/or utilize cardiac pacing procedures so that the balloon element is only inflated for a brief period of time.

Contents of the invention

The following methods and devices relate to inflation devices that allow perfusion of blood through or around the inflation device. Certain preferred embodiments involve a balloon member that allows perfusion of blood through or around the balloon member when the balloon member is inflated in the channel.

During deployment of the prosthetic device, obstruction of the channel by the balloon element during the implantation procedure - even for a short period of time - can introduce complications to the medical procedure. The devices and methods described in various embodiments herein can reduce and/or substantially eliminate occlusion of a channel during expansion of a prosthetic device therein.

The devices and methods described in various embodiments herein may allow longer prosthetic device deployment times, eliminate the need for a rapidly paced heart and its associated risks, and allow repositioning of the prosthetic device during deployment.

In a first embodiment, a system for delivering an expansion device to a treatment site is provided. The system includes an elongated rod having a distal end and an expansion device coupled to the distal end of the elongated rod and movable between a collapsed configuration and an expanded configuration. The expansion device has a distal end and a proximal end, and the expansion device may include an inner expandable element and a plurality of outer expandable elements. A plurality of outer expandable elements may at least partially surround the inner expandable element.

In particular implementations, the inner expandable element is expandable independently of the plurality of outer expandable elements. In other implementations, one or more of the plurality of outer expandable elements is expandable independently of other of the plurality of outer expandable elements. In other implementations, the plurality of outer expandable elements are not fixed relative to the outer surface of the inner expandable element at a region between the proximal and distal ends of the expandable elements. Optionally, in other implementations, a plurality of outer expandable elements may be secured at the proximal and distal ends of the expandable elements.

In other implementations, the inner expandable member may comprise a plurality of inner balloon members. In other implementations, at least some of the outer expandable elements are in contact with only one inner balloon element when the expandable element is in its expanded configuration.

In other implementations, the inner expandable member includes a plurality of struts having proximal and distal ends. The proximal and distal ends of the struts are movable from a first orientation in which the proximal and distal ends of the struts are further apart to a second orientation in which the proximal and distal ends of the struts are closer together. In the first orientation, the inner expandable element is in the collapsed configuration and in the second orientation the inner expandable element is in the expanded configuration.

In other implementations, the inner expandable member can include a first inner balloon member and a second inner balloon member. The first inner balloon member may have a smaller inflated diameter than the second inner balloon member. The first and second inner balloon members may be substantially coaxial with each other, and the first and second inner balloon members may be inflated independently of each other.

In other implementations, the prosthetic device can be provided in a crimped configuration, and the outer expandable member can have an outer surface configured to engage the prosthetic device. In other implementations, the prosthetic device may be a prosthetic heart valve having leaflets forming a plurality of commissures, and one or more of the prosthetic device commissures with an outer expandable element. In a spaced orientation, the prosthetic heart valve can be configured to rest on an outer surface of the outer expandable member.

In other implementations, the inner expandable element has a distal end, a proximal end, and an intermediate portion between the distal and proximal ends, and the intermediate portion has a smaller diameter than the distal end when the inner expandable element is in the expanded configuration. the diameter of the section. In other implementations, gaps are provided between adjacent outer expandable elements when the expandable elements are in the expanded configuration. In other implementations, the inner expandable member and the outer expandable member comprise balloon members. In other implementations, a perfusion lumen may extend through the stem between the distal and proximal ends of the expandable element to provide additional passage for blood through the expandable element during use.

In another embodiment, a system for delivering an expandable element to a treatment site is provided. The delivery system includes an elongated shaft having a distal end and an expandable member coupled to the distal end of the elongated shaft and movable between a collapsed configuration and an expanded configuration. The expandable element may have a distal end and a proximal end, and the expandable element may include a plurality of protrusions protruding from a surface of the expandable element. The plurality of protrusions can define at least one channel between the distal end and the proximal end of the expandable element when the expandable element is in the expanded configuration.

In other implementations, the expandable member can be a balloon member. In other implementations, the at least one channel can include at least one longitudinal channel and at least one circumferential channel between the distal and proximal ends of the expandable element. In other implementations, the channel can comprise a substantially helical channel between the distal and proximal ends of the expandable element. In other implementations, the expandable element can include a plurality of regions having a generally circular cross-section along the length of the expandable element.

In another embodiment, an apparatus for delivering a prosthetic valve through the vasculature of a patient is provided. The device includes a main catheter including an elongated shaft; and a balloon catheter having an elongated shaft with at least one opening extending through a side surface of the shaft and a balloon member connected to the distal end of the shaft. The shaft of the balloon catheter may be movable longitudinally within the main catheter shaft. The balloon catheter may include a perfusion lumen extending through at least a portion of the balloon catheter, the lumen being configured to allow blood to pass through the lumen when the balloon member is in an inflated state, the blood passing through an opening in the shaft of the balloon catheter.

In other implementations, at least a portion of the balloon catheter under the balloon member (e.g., in the installation area of the prosthetic valve) can include a collapsible portion that operates in a deflated state that reduces the lumen diameter and an expanded state that increases the lumen diameter can be moved between. In other implementations, the lumen can include a plurality of separate channels extending between the proximal and distal ends of the balloon member.

In another embodiment, a method of delivering an expandable member through the vasculature of a patient is provided. The method may include the act of providing an expandable member at the distal end of the elongated rod, the expandable member having a distal end and a proximal end, the expandable member comprising an inner expandable member and a plurality of outer expandable members at least partially surrounding the inner expandable member. An expandable member; delivering the expandable member to a treatment site; expanding an inner expandable member in a channel in a patient; expanding a plurality of outer expandable members in the channel; and allowing blood to pass between the inner surface of the channel and the inner and A plurality of gaps formed between the outer expandable elements.

In other implementations, the method can also include the acts of providing a prosthetic device, disposing the prosthetic device on the expandable member, and deploying the prosthetic device within the passageway by the acts of expanding the inner and outer expandable members.

In other implementations, the act of expanding the inner expandable element can occur independently of the act of expanding the outer expandable element. In other implementations, the inner expandable member can include a first inner balloon member having a first diameter and a second inner balloon member having a second diameter. The first diameter may be smaller than the second diameter and the first and second balloon members may be substantially coaxial with each other. The act of expanding the inner expandable member may include first expanding the first inner balloon member and then expanding the second inner balloon member. In other implementations, the act of expanding the outer expandable elements may include expanding one or more of the outer expandable elements and then expanding the other outer expandable elements.

The foregoing and other objects, features and advantages of the present invention will become more apparent from the following detailed description made with reference to the accompanying drawings.

Brief description of the drawings

Figure 1 illustrates a delivery system with an expansion device positioned along a distal end.

Figure 2A illustrates a partial cross-sectional view of a portion of the delivery system, showing the expansion device in an expanded configuration.

Figure 2B illustrates a close-up view of the delivery system of Figure 2A.

Figure 3 illustrates a view of the expansion device of the delivery system, shown in an expanded configuration.

Figure 4 illustrates an end view of the expansion device of the delivery system, shown in an expanded configuration in a loop.

Figure 5A illustrates a view of the expansion device of the delivery system, shown in an expanded configuration.

Figure 5B illustrates a cross-sectional view taken along line 5B-5B of Figure 5A.

Figure 6 illustrates a cross-sectional view of an optional expansion device of the delivery system.

Figure 7 illustrates a cross-sectional view of the expansion device, shown in the collapsed state and positioned in the annulus, with the prosthetic device mounted thereon.

Figure 8 illustrates a cross-sectional view of the expansion device of Figure 7, shown in a partially expanded state.

Figure 9 illustrates a cross-sectional view of the expansion device of Figure 7, shown in a fully expanded state.

Figure 10 illustrates a cross-sectional view of the expansion device of Figure 7, shown in an expanded state, with some of the outer balloon elements deflated.

Figure 11 illustrates a cross-sectional view of an expansion device, shown in a collapsed state and positioned in an annulus with a prosthetic device mounted thereon.

Figure 12 illustrates a cross-sectional view of the expansion device of Figure 11, shown in a partially expanded state.

Figure 13 illustrates a cross-sectional view of the expansion device of Figure 11, shown in a fully expanded state.

Figure 14 illustrates a partial cross-sectional view of an expansion device with a prosthetic device mounted thereon.

Figure 15 diagrammatically shows the expansion device in an expanded state with one or more blood perfusion channels between the distal and proximal ends of the expansion device.

Figure 16 diagrammatically shows the expansion device in an expanded state with one or more blood perfusion channels between the distal and proximal ends of the expansion device.

Figure 17 diagrammatically shows the expansion device in an expanded state with one or more blood perfusion channels between the distal and proximal ends of the expansion device.

Figure 18A illustrates a side view of an expansion device, with an inner balloon member and a plurality of separate outer balloon members, shown in a collapsed configuration.

Figure 18B illustrates a side view of the expansion device of Figure 18A, shown in an expanded configuration.

Figure 19A illustrates a side view of an expansion device with an inner balloon member and an outer balloon member surrounding the inner balloon member, shown in a collapsed configuration.

Figure 19B illustrates a side view of the expansion device of Figure 19A, shown in a partially expanded configuration.

Figure 19C illustrates a side view of the expansion device of Figure 19A, shown in an expanded configuration.

20 illustrates a partial cross-sectional view of a delivery system with one or more perfusion lumens.

21 illustrates a partial cross-sectional view of the delivery system of FIG. 20 showing the expansion device in an expanded configuration.

22 illustrates a partial cross-sectional view of a delivery system having one or more perfusion lumens and a collapsible portion.

Figure 23 illustrates a side view of an inflation device with an inner balloon member and one or more perfusion lumens.

Figure 24 illustrates a side view of an expansion device with an inner balloon member and one or more perfusion lumens.

25A illustrates a partial cross-sectional view of a delivery system with one or more perfusion lumens.

Figure 25B illustrates a cross-sectional view of the delivery system of Figure 25A taken along line 25B-25B.

26A illustrates a partial cross-sectional view of a delivery system with one or more perfusion lumens.

Figure 26B illustrates a cross-sectional view of the delivery system of Figure 26A taken along line 26B-26B.

Figure 27 illustrates a delivery system and methods and apparatus for securing a prosthetic device to the distal end of the delivery system.

Figure 28 illustrates a delivery system and methods and apparatus for securing a prosthetic device to the distal end of the delivery system.

Figure 29 illustrates a delivery system and methods and apparatus for securing a prosthetic device to the distal end of the delivery system.

Figure 30 illustrates a delivery system and methods and apparatus for securing a prosthetic device to the distal end of the delivery system.

Figure 31 illustrates a delivery system and methods and apparatus for securing a prosthetic device to the distal end of the delivery system.

Figure 32 illustrates an inflation device with a mechanical inner inflation device and a plurality of outer balloon elements, shown in a non-expanded (deflated) configuration.

Figure 33 illustrates an expansion device with a mechanical inner expandable element and a plurality of outer balloon elements, shown in a partially expanded configuration.

Figure 34 illustrates an expansion device having a mechanical inner expandable element and a plurality of outer balloon elements, shown in an expanded configuration.

Figure 35 illustrates the embodiment of the expansion device of Figure 32, shown in a non-expanded (deflated) configuration, with the outer balloon member and most of the struts removed for clarity.

Figure 36 illustrates the embodiment of the expansion device of Figure 32, shown in an expanded configuration, with the outer balloon member and most of the struts removed for clarity.

Figure 37 illustrates the embodiment of the expansion device of Figure 32, shown in an expanded configuration with most of the outer balloon elements and struts removed for clarity.

38A illustrates a method of delivering a prosthetic device in a collapsed configuration to a treatment site in a native arterial valve annulus.

38B illustrates a method of deploying the prosthetic device of FIG. 38A in a native arterial annulus using the expansion device of FIG. 3 .

Figure 38C illustrates the prosthetic device of Figure 38A in a deployed state in the native arterial valve annulus.

Figure 39 is a schematic illustration of a calcified native arterial valve annulus.

Figure 40 illustrates a prosthetic heart valve mounted on an expansion device.

Figure 41 illustrates another embodiment of a prosthetic heart valve mounted on an expansion device.

Figure 42 illustrates an embodiment of an expansion device with multiple outer balloon elements having a shorter working length.

43A is a cross-sectional view taken along line 43A-43A of FIG. 42 .

43B is a cross-sectional view taken along line 43B-43B of FIG. 42 .

FIG. 44 illustrates a prosthetic heart valve installed on the expansion device shown in FIG. 42 .

Figure 45 illustrates another embodiment of a prosthetic heart valve mounted on an expansion device.

Figure 46 illustrates another embodiment of an expansion device in which a portion of the outer balloon member is attached to the outer surface of the inner balloon member.

Figure 47A illustrates another embodiment of an expansion device with tails connected and/or merged together.

Figure 47B illustrates another embodiment of an expansion device with tails merged together.

48A and 48B illustrate another embodiment of an expansion device with tails merged together.

Figure 49 illustrates an embodiment of an expansion device formed from a single balloon element.

FIG. 50A is a cross-sectional view taken along line 50A-50A of FIG. 49 .

FIG. 50B is a cross-sectional view taken along line 50B-50B of FIG. 49 .

Detailed description of the invention

The following description is exemplary in nature and is not intended to limit the scope, applicability, or configuration of the invention in any way. Many changes may be made to the described embodiments in the function and arrangement of elements described herein without departing from the scope of the invention.

As used in this application and the claims, the singular forms "a", "an" and "the" include plural referents unless the context clearly dictates otherwise. Additionally, the term "comprises" means "comprises." Further, the terms "bonded" and "connected" generally mean electrical, electromagnetic, and/or physical (e.g., mechanical or chemical) bonding or connection, and are not excluded in the absence of specific opposite language bonding or connection items There are intermediate elements.

Although, for ease of presentation, the operations of exemplary embodiments of the disclosed methods may be described in a specific, sequential order, it should be understood that the disclosed embodiments may include orders of operations that differ from the specific, sequential order disclosed. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Further, descriptions and disclosures provided in connection with a particular embodiment are not limited to that embodiment, and may apply to any embodiment disclosed.

Moreover, for the sake of simplicity, the accompanying drawings may not show the various situations in which the disclosed systems, methods, and apparatuses may be used in conjunction with other systems, methods, and apparatuses as would be readily understood by one of ordinary skill in the art based on this disclosure. Additionally, the specification sometimes uses terms such as "produce" and "provide" to describe the disclosed methods. These terms are high-level abstractions of actual operations that can be implemented. The actual operations corresponding to these terms may vary depending on the specific implementation and can be readily understood by those of ordinary skill in the art based on this disclosure.

Figure 1 shows a delivery device 10 suitable for delivering a prosthetic heart valve 12 (eg, a prosthetic arterial valve) to the heart. Device 10 generally includes a steerable guide catheter 14 , and a balloon catheter 16 extending through guide catheter 14 . Balloon catheter 16 may include multiple lumens to independently deliver fluid to one or more regions of the inflation device, as described in more detail below. A guide catheter may also be called a flexible catheter or main catheter. As shown in FIGS. 38A-38C and described in more detail below, prosthetic valve 12 may be configured to deploy within the patient's aortic annulus.

Guide catheter 14 may include a handle 20 and an elongate guide tube or stem 22 extending from handle 20 . Balloon catheter 16 may include a proximal end 24 adjacent handle 20 and an elongate shaft 26 extending from proximal end 24 and through handle 20 and guide tube 22 . The handle 20 may include a side arm 27 having an internal passageway in fluid communication with one or more lumens defined by the handle 20 . An inflation device 28 (eg, a plurality of inflatable balloons) may be mounted at the distal end of balloon catheter 16 . In FIG. 1 , prosthetic valve 12 is mounted on expansion device 28 and is shown in a crimped state, providing a reduced diameter prosthetic valve 12 for delivery to the heart through the patient's vasculature. It should be appreciated that the expansion device 28 may be configured for delivery to a treatment site without a prosthetic heart valve installed thereon, for off-expansion device delivery of a prosthetic valve to the treatment site (as discussed below) or for delivery of a prosthetic heart valve to the treatment site (as discussed below) or for delivery of a prosthetic heart valve to a treatment site after an annuloplasty Expansion devices are used during surgery.

While the illustrated embodiments discussed herein relate to delivery of a prosthetic heart valve crimped or mounted on an expansion device to a treatment site, it should be understood that a prosthetic heart valve may be crimped or mounted at a location other than that of the expansion device (e.g., the distal or proximal) and can be repositioned on the expansion device at some point before the expansion device is expanded and the prosthetic valve is deployed. This non-expandable device/off-ballon delivery allows the prosthetic valve to be crimped to a lower profile than would be possible if the prosthetic valve were crimped on an inflatable device. The lower profile allows the physician to more easily navigate the delivery device, including the crimped prosthetic valve, through the patient's vasculature to the treatment site. A lower profile crimped prosthetic valve may be especially useful when navigating through particularly narrow portions of a patient's vasculature, such as the iliac arteries.

A nose piece 32 may be mounted on the distal end of the delivery device 10 to facilitate advancement of the delivery device 10 through the patient's vasculature to the implantation site. In some instances, it may be useful to have the nozzle 32 attached to a separate elongate rod so that the nozzle 32 can move independently of the other elements of the delivery device 10 .

Nozzle 32 may be formed from various materials, including various plastic materials. Optionally, nozzle 32 may comprise an inflatable balloon member. When expanded, the nozzle 32 may generally form a cone, as shown in FIG. 1 . When nozzle 32 comprises a balloon element, inflation of nozzle 32 may be accomplished by extending a lumen from the proximal end of the delivery device to nozzle 32 . A fluid pressurization device may be in fluid contact with the cavity, and the nozzle 32 may be expanded and deflated by the fluid pressurization device. The nozzle 32 can be inflated to help follow the nozzle 32 through the patient's vasculature and/or provide an abutable surface for the prosthetic valve 12 that can help maintain the position of the prosthetic valve 12 on the delivery device until deployed at the treatment site. In other embodiments discussed in more detail below, the nozzle 32 may have one or more lumens to provide perfusion of blood through the nozzle 32 .

As shown in FIGS. 2A and 2B , in the illustrated configuration, the balloon catheter 16 may further include an inner shaft 34 ( FIG. 2B ) extending from the proximal end 24 and extending coaxially through the outer shaft 26 and the inflation device. 28. The expansion device 28 may be supported on a distal portion of an inner rod 34 extending outwardly from the outer rod 26 to which a proximal end 36 of the expansion device is secured (eg, using a suitable adhesive). The outer diameter of the inner rod 34 is sized to define an annular space between the inner rod and the outer rod along the entire length of the outer rod. The proximal end 24 of the balloon catheter may be formed with a fluid channel 38, which may be fluidly connected to a source of fluid (eg, a source of saline) for inflating the expansion device. Fluid passage 38 is in fluid communication with the annular space between inner rod 34 and outer rod 26, so that fluid from a fluid source can flow through fluid passage 38, through the space between the rods, and into inflation device 28 to inflate and deploy it. Prosthetic valve 12.

Proximal portion 24 also defines an interior lumen 40 that communicates with lumen 42 of inner stem 34 . In the illustrated embodiment, the cavities 40, 42 are sized to receive the stem of a nasal cannula, if desired. The inner shaft 34 and outer shaft 26 of the balloon catheter 16 may be formed from any of a variety of suitable materials, such as nylon, braided stainless steel wire, or polyether block amide (commercially available as ). The rods 26, 34 may have longitudinal portions formed from different materials in order to vary the flexibility of the rods along their length. The inner rod 34 may have a The inner lining or layer is formed to minimize sliding friction with the nasal cannula shaft.

The expansion device 28 may include a plurality of balloon elements, including, for example, an inner balloon element 50 and a plurality of outer balloon elements 52, as shown in Figures 2A and 2B. As shown more clearly in FIGS. 3 and 4 , a plurality of outer balloon members 52 desirably at least partially surround inner balloon member 50 . Outer balloon member 52 may be angularly spaced about the outer surface of inner balloon member 50 at substantially equal intervals, as shown.

Each outer balloon member 52 also preferably extends axially along the outer surface 54 of the inner balloon member 50 . The outer balloon member 52 may include a major outer surface 53 configured to receive and urge against the prosthetic valve (i.e., to radially expand the prosthetic heart valve) and/or configured to compress the inner surface of the passageway (i.e., to urge against the prosthetic heart valve). during surgery). Additionally, each outer balloon member 52 may include one or more narrowed portions 55 located distally and/or proximally to major outer surface 53 .

As best seen in FIG. 3 , outer balloon member 52 is preferably secured at proximal end 56 and distal end 58 of inner balloon member 50 . The proximal and distal ends 56 , 58 of the outer balloon member 52 may be secured to the inner balloon member, the outer shaft 26 , or other structures near the proximal and distal ends 56 , 58 . If the outer balloon member 52 includes a narrowed portion 55, the portion of the narrowed portion 55 closest to the proximal end 56 and the distal end 58 may be the outer balloon member fixed to the inner balloon member, outer rod, or other related structure. part.

The outer balloon member 52 may also be secured to the outer surface 54 of the inner balloon member 50 at a position intermediate the proximal end 56 or the distal end 58; however, each outer balloon member 52 is desirably secured only at the proximal end 56 and the distal end 58 , so that the portion of the outer balloon member 52 between the proximal end 56 and the distal end 58 is free to move relative to the outer surface 54 of the inner balloon member 50 . By not securing outer balloon member 52 to outer surface 54 of inner balloon member 50 , outer balloon member 52 is free to move along outer surface 54 . This free movement allows the outer balloon elements 52 to achieve a lower profile when compressed, as they are able to align themselves and/or move into the gaps of the compressed profile of the expansion device 28 .

As shown in FIG. 4, one or more gaps 60 are preferably provided between at least two adjacent outer balloon members when the inflation device 28 is expanded (inflated) in the annulus 61 (or other similar hole or passage in the body). Between 52. Preferably, each outer balloon member 52 is spaced apart from the adjacent outer balloon member 52 such that the side (outer) surface 62 of the first outer balloon member 52 does not contact the facing side surface of the adjacent outer balloon member 52. 62. Accordingly, the one or more gaps 60 may allow blood to perfuse through the body passage between the distal and proximal ends 56, 58 of the expansion device 28 when the expansion device 28 is in the expanded configuration.

It should be understood that the number and size of outer balloon elements 52 may vary. For example, if the final desired expanded inner diameter of the prosthetic device is about 23 mm, the expanded diameter of the expanded device may be configured in various ways to achieve this expansion. For example, the inner balloon member 50 may have an inflated diameter of about 15 mm and the seven outer balloon members ( FIG. 4 ) may each have an inflated diameter of about 4 mm. Thus, the final expanded diameter of the expanded device is about 23 mm - the same diameter as the desired inner diameter of the expanded prosthetic device. In another example, inner balloon member 50 may have an expanded diameter of about 17 mm. If the prosthetic device should be expanded to about 23 mm (as described in the previous example), the expanded diameter of the outer balloon member 52 should be smaller than in the previous example. In this case, for example, the expanded diameter of the outer balloon member 52 may be about 3 mm to achieve the same expanded diameter as in the previous example (ie, 23 mm).

In some embodiments, there are at least 5 outer balloon elements. By providing at least 5 outer balloon elements, the cross-section of the outer profile of the expansion device can be approximately circular. More preferably, as shown in Figure 4, there are at least 7 outer balloon elements to provide a more rounded cross-sectional profile to the outer profile of the expansion device. As described in more detail below, an approximately circular cross-section may be particularly desirable when expanding a prosthetic heart valve using the expansion devices disclosed herein.

FIG. 5A illustrates another embodiment of an expansion device 28 that includes an inner balloon member 50 and a plurality of outer balloon members 52 . FIG. 5B illustrates a cross-sectional view of the expansion device 28 showing that this embodiment includes eight outer balloon members 52 . As discussed above, the outer balloon member 52 is preferably not secured to the inner balloon member 50 between the proximal end 56 and the distal end 58 of the expansion device 28 . Each outer balloon member 52 may be secured at its respective proximal or distal end to the proximal and distal ends of the inner balloon member, respectively. If desired, outer balloon member 52 may taper to a smaller diameter (as shown in FIG. 5A ) or have narrowed portions at proximal end 56 and distal end 58 (as shown in FIG. 3 ).

Referring to Figure 6, a cross-sectional view of another embodiment is provided. In the embodiment shown in FIG. 6 , the expansion device 70 includes a plurality of inner balloon elements 72 and a plurality of outer balloon elements 74 . The shaft 76 of the balloon catheter may extend between the inner balloon elements 72 past the inflation device.

Multiple inner balloon elements 72 may be used to create balloon assemblies capable of various shapes. For example, three inner balloon elements 72 may be used to create an inflated shape that is generally tri-lobular in cross-section (as shown in FIG. 6 ). For example, a triangular shape may be useful when expanding a prosthetic valve in portions of the aortic valve and/or aortic root. Optionally, the inner and outer balloon elements may be selected such that the expanded shape of the expansion device is substantially circular in cross-section, as in the embodiments described above. Of course, in the embodiments described above with a single inner balloon member, the size (i.e., inflated diameter) of the outer balloon member can be altered to form non-circular shaped cross-sections (e.g., triangular, elliptical) if desired. .

In each of the embodiments herein, the balloon elements of the expansion device may be inflated (expanded) simultaneously or they may be expanded separately (eg, sequentially or in one or more stages). Preferably, each inner balloon member is fluidly separate or distinct from each outer balloon member. Similarly, each outer balloon element may be fluidly separate or distinct from the other outer balloon elements. By individually inflating at least some of the balloon elements, the passageway in which the expansion device is inflated may be partially or completely occluded for a short period of time. For example, FIGS. 7-13 illustrate various stages of expansion of an expansion device, which may be configured to expand a prosthetic device, such as a prosthetic heart valve, or to perform a valvuloplasty procedure.

As described in more detail below, in preferred embodiments, the external balloons can be inflated in alternating and/or sequential groups to increase blood flow between the distal end of the inflatable device to the proximal end of the inflatable device (and vice versa). as well). Thus, for example, if two sequentially inflatable (and deflatable) sets of outer balloon elements are provided, a first set of outer balloon elements can be inflated and then, after the first set is inflated, a second set of outer balloon elements can be expanded. Can be inflated. The first sets may remain in their expanded configuration while the second set is expanded. By inflating the outer balloon members sequentially in this manner, the amount of time that the two sets of outer balloon members are inflated can be reduced, which is beneficial because when all the outer balloon members are inflated, the distance between the ends of the expansion device is reduced. The perfusion path is reduced. Similarly, the two sets of outer balloon elements may be deflated sequentially to increase the blood perfusion path and reduce the amount of time that the perfusion path is reduced during the procedure. Although the method is described with only two sets of outer balloon elements, it should be understood that more than two sets of sequentially inflatable and/or alternately inflatable balloon elements may be provided.

Additionally, as described in more detail herein, the sequential and/or alternate inflation of elements is not limited to outer balloon elements. In various embodiments, the inner and outer elements (balloon or mechanical) can be expanded and/or deflated sequentially. For example, a first inner balloon may be inflated and then one or more outer balloons may be inflated. Alternatively, the outer element(s) may be expanded and then the inner element may be expanded.

Referring to Figure 7, the expanded device with the prosthetic device 86 crouched thereon is shown in a collapsed configuration. The expansion device includes an inner balloon member 82 and a plurality of outer balloon members 84 in a deflated configuration and supported on an inner rod 81 . Seven outer balloon elements 84 are shown, but as discussed above, in some embodiments the number of outer balloon elements may be fewer or greater. The prosthetic device 86 is crimped over the contracted expansion device. As discussed above, each outer balloon member 84 preferably has a freely floating or movable portion (e.g., a central longitudinal or axial portion) relative to the balloon member 82, which allows the outer balloon member 84 to deflate. to lower profile shapes. To deploy (expand) the prosthetic device 86, the expansion device and the prosthetic device 86 may be moved to the treatment site (eg, a body passage or hole) where the prosthetic device is to be expanded. The treatment site may be, for example, the native valve annulus 80, as shown in Figures 7-8. As can be seen in FIG. 7 , blood can pass through the annulus in the space between the outer surface of the crimped prosthetic device 86 and the inner surface of the annulus 80 when the expansion device on which the prosthetic valve rests is fully deflated.

Referring to Figure 8, the first stage of deployment may include partially inflating the expansion device by inflating the inner balloon member 82 to its expanded configuration. Inflation of the inner balloon member 82 causes partial expansion of the prosthetic device 86 as shown in FIG. 8 . Thus, the inner balloon member 82 can be expanded while the outer balloon members 84 remain in their collapsed configuration. To facilitate independent and/or separate inflation of the inner and outer balloon elements, separate lumens may be provided. In some embodiments, the separate chambers may be in a side-by-side configuration; however, it should be understood that other configurations are possible.

The inner balloon member 82 is preferably inflated to a size sufficient to maintain friction against the prosthetic device 86 . If desired, the prosthetic device 86 can be repositioned as desired by moving the expansion device (eg, by moving the inner rod 81 in a proximal or distal direction). Friction against the prosthetic device 86 may help maintain the position of the prosthetic device 86 over the expansion device.

As shown in FIG. 8, because the outer diameter of the partially expanded expansion device and prosthetic device 86 is smaller than the inner diameter of the ring, blood can still pass through the outer surface of the partially expanded prosthetic device 86 and the inner surface of the ring 80. rings in the space between.

Referring to Figure 9, the expansion device is shown in a further expanded configuration (eg, a fully inflated configuration) with the inner balloon member 82 in an inflated state and the outer balloon member 84 in an inflated state. Sufficient expansion of the expansion device also expands the prosthetic device 86 to its fully deployed state. As can be seen in FIG. 9 , and as discussed above with respect to FIG. 4 , gaps 60 exist between inner balloon member 82 and outer balloon member 84 and between ring 80 and inner balloon member 82 . These gaps allow blood to pass between the proximal and distal ends of the prosthetic device 86 when the expansion device is fully inflated.

Thus, as shown in Figures 7-9, the expansion device can expand the prosthetic device while allowing blood to perfuse between the proximal and distal ends of the expansion device. Also, the expansion device expands in stages during deployment of the prosthetic device (or during a valvuloplasty procedure) to maximize blood flow. Also, because the inner balloon member 82 can be fully inflated when the prosthetic device is in the partially expanded configuration, the size and shape of the partially expanded expansion device is predictable. In contrast, while conventional balloon elements may be partially inflated during inflation of a delivery device, the shape of conventional balloon elements is generally unpredictable during inflation because the balloon element does not tend to conform to the predicted shape until Sufficient inflation of the balloon element is achieved.

In some embodiments, the outer balloon member 84 can be inflated before the inner balloon member 82 is inflated. Preferably, when the outer balloon member 84 is inflated first, the outer balloon members 84 are collectively inflatable to a magnitude sufficient to maintain friction against the prosthetic device 86 to achieve the same repositionability as with the inner ball above. The embodiment in which the balloon member 82 is first inflated is described.

In another embodiment, the outer balloon members 84 are separately inflatable relative to each other. Thus, as shown in FIG. 10, the inner balloon member 82 may be inflated to partially expand the prosthetic device 86, and then the outer balloon member 84 may be expanded in stages. For example, as shown in FIG. 10, alternating outer balloon members 84 are shown in an inflated state. In this way, the gap 60 that exists between the inner balloon member 82 and the ring 80 is larger than those gaps described above in FIG. 9 , and more blood perfusion is possible through the gap 60 .

The configuration shown in 10 may be an illustration of the stage of deployment of the prosthetic device 86 or it may be an illustration of the contraction of the expansion device after the deployment of the prosthetic device 86 . That is, the deflated outer balloon member 84 shown in FIG. 10 may be in an intermediate stage and then expanded to assist in expansion of the prosthetic device 86 . Alternatively, the configuration shown in FIG. 10 may be an illustration of the selective deflation (deflation) of one or more outer balloon members 84 after the prosthetic device 86 has been fully deployed. Thus, an expanding device can rapidly reduce its profile to allow increased blood perfusion, and then be fully deflated or contracted.

Following expansion of the expansion device (eg, to expand a prosthetic device or perform valvuloplasty), the expansion device may also be deflated or deflated in stages. For example, the outer balloon(s) may be deflated before the inner balloon(s) are deflated. In this way, blood may be allowed to pass between the proximal and distal ends of the inflation device in the region adjacent to the deflated balloon member and the urgency to deflate the remaining inflated balloon member may be alleviated.

In another embodiment, the inflation device may comprise a multi-diameter inner balloon assembly consisting of a plurality of coaxially arranged inner balloon elements configured such that the inner balloon elements can be inflated to different diameter. For example, FIG. 11 illustrates an expansion device 100 with a prosthetic device 102 (eg, a prosthetic valve) crimped thereon. The expansion device 100 may include a first inner balloon member 104 and a second inner balloon member 106 . The first inner balloon member 104 and the second inner balloon member 106 are preferably coaxial. In the illustrated embodiment, first inner balloon member 104 and second balloon member 106 may both be supported on inner rod 107 . In a manner similar to that described above, a plurality of outer balloon members 108 may at least partially surround first inner balloon member 104 and second inner balloon member 106 .

The first inner balloon member 104 and the second inner balloon member 106 preferably have different diameters so that the expansion device 100 is expandable to a plurality of predictable, increasing diameters. For example, first inner balloon member 104 may have a smaller expanded diameter than second inner balloon member 106 . Thus, as shown in FIG. 12, when the expansion device 100 is inflated (inflated) to a first configuration - in which the first inner balloon member 104 is fully expanded and the outer balloon member 108 is fully expanded, the overall size of the expansion device The expanded diameter (profile) is smaller than the inner diameter of the ring 110 . However, as shown in FIG. 13, when the expansion device 100 is expanded (inflated) to the second configuration - wherein the second inner balloon member 106 is fully expanded and the outer balloon member 108 is fully expanded, the expansion device The overall expanded diameter (profile) of the ring 110 is substantially the same as the inner diameter of the ring 110.

Thus, the expansion device can be expanded (inflated) in stages, characterized by predictable, increasing diameters. That is, the expansion of the expansion device may include an intermediate stage (Fig. 12) between the deflated stage (Fig. 11) and the fully expanded stage (Fig. 13). As shown in FIG. 12 , in this intermediate stage the inflation device 100 is only partially inflated and blood can more easily pass between the proximal and distal ends of the inflation device 100 . Preferably, the first and second inner balloon members are concentric and coaxial so that they expand in a predictable and uniform manner relative to the prosthetic device. In addition, as in other embodiments, it should be understood that even at the fully inflated stage ( FIG. 13 ), blood can flow through the gap (space) 109 that exists between adjacent outer balloon elements 108 , even in the fully inflated stage ( FIG. 13 ). pass between the proximal and distal ends.

As described above, the inner element may be expanded before one or more outer elements, or one or more outer elements may be expanded before the inner element. By expanding the outer elements first, gaps (eg, channels) can be formed between adjacent outer balloon elements early in the inflation process. These gaps between adjacent outer balloons may be maintained when the inner element is inflated. In this way, as the inflation device moves from a partially inflated state to a fully inflated state, gaps exist in the inflation device and allow blood to flow through the device during the entire inflation process.

In another embodiment, the expansion device may include an inner balloon member 127 and a plurality of outer balloon members 128 at least partially surrounding the inner balloon member 127 . Outer balloon member 128 may be positioned relative to prosthetic device 120 to increase perfusion between the distal and proximal ends of prosthetic device 120 . For example, as shown in FIG. 14 , a prosthetic device 120 may include a frame member 122 and a plurality of leaflets 124 connected to the frame member 122 . Adjacent leaflets 124 form a plurality of commissures 126 . As shown in FIG. 14 , the prosthetic device 120 may be mounted on the expansion device such that the outer balloon member 128 is not aligned with (or spaced from) the commissures 126 . By positioning the outer balloon elements 128 so that they are not located in the area of the commissures 126, maximum blood perfusion between the proximal and distal ends of the prosthetic device 120 can be achieved by utilizing blood flow through the prosthetic device 120 itself.

While the balloon elements described above may be formed in various cross-sectional shapes (eg, circular, triangular, oval, etc.), preferably they are substantially circular in cross-section. Balloon elements have a tendency to "round out" when subjected to high pressure expansion, as required for inflating a prosthetic device, regardless of their pre-set shape. For example, while it is possible to heat set a balloon to have an oval cross-section, this oval shape will tend to expand to a substantially round cross-sectional shape during high pressure inflation. Thus, an advantage of the embodiments described above is that the cross-section of each balloon element (e.g., inner and outer balloon elements) can be configured to be circular, while the overall profile of the cross-section of the inflation device is more complex and includes gaps for blood perfusion. . Thus, even when undergoing high pressure inflation, the final shape of the expansion device is substantially the same as its predetermined shape, since each balloon has a predetermined shape having a substantially circular cross-sectional profile. Conversely, a balloon member having a non-circular cross-sectional profile may deform when inflated at high pressure, and the final shape of the balloon member may not be as desired.

In another embodiment, other inflation devices are provided that prevent and/or minimize deformation of the balloon member when subjected to high pressure inflation. Referring to Figure 15, an expansion device 150 having a plurality of protrusions is disclosed. The expansion device 150 includes a main body 152 and a plurality of protrusions 154 extending radially from the main body 152 and extending circumferentially around the main body. Protruding portion 154 defines a groove 156 along inflation device 150 to allow passage of blood from proximal end 158 to distal end 160 of the inflation device. Protruding portion 154 preferably defines a longitudinal groove 162 and a circumferential groove 164 . The longitudinal groove 162 extends in a substantially longitudinal direction between the proximal end 158 and the distal end 160 , while the circumferential groove 164 extends in a circumferential direction around the expansion device 150 . Preferably, the longitudinal groove 162 extends substantially the length of the expansion device 150 and the circumferential groove 164 extends substantially around the circumference of the body 152; Grooves 162 and circumferential grooves 164 collectively form one or more channels between proximal end 158 and distal end 160 of expansion device 150 , and expansion device 150 is effective to allow passage of blood between the two ends 158 , 160 .

As stated above, when subjected to high pressures, balloon elements have a tendency to deform towards a circular cross-sectional configuration. The circumferential groove 164 serves to minimize the detrimental effects of distension pressure. Specifically, because the circumferential grooves 164 preferably extend around the circumference of the inflation device 150, the inflation device 150 can achieve a circular cross-section when expanded at those locations such that at other locations along the length of the balloon member Deformation of the expansion device 150 is minimized. In other words, by making the part of the expansion device 150 at the groove a circular cross-section, deformation forces at other locations along the longitudinal axis of the expansion device 150 are prevented or at least minimized.

Accordingly, the expansion device 150 may have a plurality of circular cross-sectional areas extending along the length of the expansion device 150 . In particular, such a circular cross-sectional area may be at the location of one or more circumferential grooves. Additionally, because the expansion device has protrusions and grooves formed between the protrusions, the expansion device desirably has a number of different cross-sectional shapes/sizes along the length of the expansion device 150 . For example, the cross-section at the circumferential groove may be circular and have a certain size (diameter), while the cross-section at other locations may be non-circular and larger than the cross-section of the circumferential groove.

FIG. 16 illustrates another embodiment of an expansion device 150 . The expansion device of FIG. 16 includes fewer protrusions 154 than the expansion device of FIG. 15 . In addition, the protruding portion 154 of FIG. 16 is circular or tapered in the circumferential direction. These circular portions 166 reduce the likelihood of "blow-out" of non-circular portions. As in FIG. 15 , the longitudinal groove 162 extends in a substantially longitudinal direction between the proximal end 158 and the distal end 160 , while the circumferential groove 164 extends in a circumferential direction around the expansion device 150 .

While each expansion device 150 is shown in FIGS. 15 and 16 as having protrusions evenly distributed in a grid-like fashion, it should be understood that the protrusions may be non-uniformly spaced along the body of the expansion device 150 .

In another embodiment, an expansion device 170 is provided. As shown in FIG. 17 , expansion device 170 includes an inner balloon member 172 and an outer balloon member (or protrusion) 174 that extends from a proximal end 176 to a distal end 178 of expansion device 170 . Outer balloon member 174 extends from proximal end 176 to distal end 178 by wrapping one or more turns around the body of inner balloon member 172 . Preferably, the outer balloon member 174 is wrapped around the inner balloon member 172 in a substantially helical manner as shown in FIG. 17 . Thus, when inner balloon member 172 and outer balloon member 174 are inflated, blood can perfuse between proximal end 176 and distal end 178 through channel 180 formed between adjacent radially projecting portions of outer balloon member 174. . If the outer balloon member 174 extends in a substantially helical configuration around the surface of the inner balloon member 172, the shape of the resulting channel will also be substantially helical.

Outer balloon member 174 is preferably connected to inner balloon member 172 so as to maintain the helical shape when outer balloon member 174 is inflated. However, it may be preferable to leave a portion of the outer balloon member free (not attached to the inner balloon member 172) so that the expansion device 170 may have a smaller reduced profile when the balloon member is deflated. In other words, the outer balloon member 174 can align itself by moving into a gap in the compressed profile of the expansion device 170 as described above with respect to the embodiment shown in FIG. 3 .

As discussed above, the balloon member preferably has a circular cross-section to prevent or reduce the chance of deformation of the balloon member when inflated. However, other shapes may be advantageous. For example, Figures 18A and 18B illustrate an expansion device 190 similar to that shown in Figures 3 and 4, except that the inner balloon member 192 is peanut-shaped or dog-bone-shaped. That is, portions of inner balloon member 192 near proximal end 194 and distal end 196 have a wider radius than portions at the center. A plurality of outer balloon members 198 extend substantially the length of inner balloon member 192 . The outer balloon member may be configured in the same or substantially similar manner as the outer balloon member of the other embodiments. For example, as described above with respect to FIGS. 3 and 4 , outer balloon member 198 may be attached to inner balloon member 192 at proximal end 194 and distal end 196 so that each The central region of the outer balloon element is not attached to the inner balloon element.

As discussed above and shown, for example in FIG. 4 , the outer balloon member may be configured to provide a gap for perfusing blood between adjacent balloon members. The use of an inner balloon member shaped as shown in FIGS. 18A and 18B may be advantageous when used in conjunction with multiple outer balloon members because it may allow for even more space between the proximal and distal ends of the expansion device. Much flow. In particular, because the outer balloon member 198 is preferably not attached to the central region, when inflated, the inner surface of the outer balloon member 198 can be spaced apart from the inner balloon member 192, which creates a gap between the outer balloon member 198 and the inner balloon member 198. Additional gaps 199 are defined between the bladder elements 192 . These additional gaps 199 may further facilitate blood flow between the proximal end 194 and the distal end 196 .

Also, the dog-bone shape of the inner balloon member 192 can help stabilize the prosthetic valve on the expansion device during the expansion process. That is, the prosthetic valve may be mounted on the prosthetic valve between the proximal end 194 and the distal end 196 so that at least a portion of the two bulbous or radially enlarged regions (i.e., the wide portion of the dog-bone-shaped inner balloon element) are respectively Extends beyond the proximal and distal ends of the prosthetic device.

When the prosthetic valve is deployed in the annulus (eg, the aortic annulus), inner balloon member 192 can be inflated to stabilize the prosthetic valve on the expansion device. By fitting the prosthetic valve between two bulbous regions of the inner balloon member 192, the prosthetic valve can be securely retained on the inner balloon member 192. If desired, the position of the prosthetic valve in the annulus can be adjusted while the prosthetic valve is securely mounted on the expansion device. Once the prosthetic valve is in the proper deployed position, one or more outer balloon members 198 can be inflated, as shown in Figure 18B, to fully deploy the prosthetic valve in the annulus. As outer balloon member 198 expands, outer balloon member 198 presses against the inner surface of the prosthetic valve and causes the prosthetic valve to expand to its expanded configuration. Although following the curve of the inner balloon member 192, the outer balloon member 198 is shown in FIG. (for example, a straight line).

19A-19C illustrate another embodiment of an expansion device. The expansion device 190 of FIGS. 19A-19C is similar to the expansion device shown in FIGS. 18A and 18B , except that instead of multiple outer balloon members, there is a single outer balloon member 198 surrounding the inner balloon member 192 . As in the embodiment of Figures 18A and 18B, the inner balloon member 192 may be inflated to stabilize or secure the prosthetic device on the inner balloon member 192 (Figure 19B). Next, the prosthetic device can be fully deployed in the annulus by inflating the outer balloon member 198 (Fig. 19C). Although the embodiment of FIGS. 19A-19C includes a dog-bone shaped inner balloon member 192, it does not provide a gap 199 as shown in FIGS. 18A-18B because the outer balloon member 198 fully surrounds the inner balloon in this embodiment. Element 192.

In other embodiments, other techniques, devices, and methods may be used to increase blood perfusion between the proximal and distal ends of the expansion device mounted at the distal end of the delivery device. Figure 20 illustrates a perfusion device or catheter assembly 200 that includes an inner tube or catheter 202 through which a lumen 204 passes. A balloon member 206 can extend over a portion of the inner tube 202 and a prosthetic device 208 (eg, a prosthetic valve) can be crimped over the balloon member 206 . An outer tube, housing or conduit 210 (the housing) may extend along at least a portion of the inner tube 202 . A nose cone 212 may be provided at the distal end of the inner tube 202 . Balloon member 206 may comprise a conventional inflatable balloon or one of the inflation devices described herein.

Lumen 204 may be configured to receive a guidewire (not shown). After the prosthetic device is advanced to a deployed position for expansion in the body, the guidewire can be removed from the lumen 204 (or at least from the distal end of the lumen) and blood can be allowed to pass through the distal end 216 and the proximal end of the balloon element 206. 214 between perfusion. Referring to FIG. 20 , blood can flow through nose cone 212 and lumen 204 in the direction of arrow 218 . To facilitate blood flow out of lumen 204 , one or more openings 220 may be provided in inner tube 202 . Also, if the outer tube 210 is located above the inner tube 202 , the outer tube 210 may also include a plurality of openings 222 . Preferably, the opening 222 in the outer tube 210 can be aligned or placed adjacent to the opening 220 in the inner tube 202 to facilitate the flow of blood out of the lumen at the proximal end 214 of the balloon member 206 .

FIG. 21 illustrates the perfusion device 200 of FIG. 20 in an expanded configuration. As shown in FIG. 21 , balloon member 206 may be inflated to deploy prosthetic device 208 . During inflation of balloon member 206 , blood flow between the distal and proximal ends of balloon member 206 may be restricted by balloon member 206 . However, by providing an inner channel (lumen 204) through which blood can flow, the restriction of blood flow through the channel can be reduced. Additionally, blood perfusion can be further increased if the perfusion device 200 is used with the inner and outer balloon member configurations disclosed in other embodiments.

In a variation of perfusion device 200 , inner tube 202 may include a collapsible element or collapsible portion 226 as shown in FIG. 22 . Thus, as shown in FIG. 22, the collapsible member 226 can receive the crimped prosthetic device 208 and achieve a lower profile by contracting to a smaller diameter when the prosthetic device 208 is crimped thereon. Because blood perfusion through lumen 204 is primarily required when balloon element 206 is in the expanded configuration (FIG. 21), the narrow lumen 204 of collapsible element 226 is No significant restriction of blood flow.

When the compressive force on the collapsible member 226 is removed by expanding the balloon member 206, the collapsible member 226 desirably returns to a larger diameter configuration (such as that shown in FIG. 21 ). Conventional tube materials may not recover enough to allow adequate blood flow through the lumen. Additionally, conventional tubes can bend, break or otherwise fail when squeezed (contracted) by the force of crimping the prosthetic valve, or when subsequently inflated by the inward force applied by balloon member 206 during expansion. Accordingly, the collapsible member 226 is preferably formed from a resilient material, such as Nitinol (nickel-titanium intermetallic compound). In a preferred embodiment, the collapsible element 226 comprises a braid formed from Nitinol.

As discussed above, a perfusion lumen may be used in conjunction with the multi-balloon inflation devices described herein. For example, FIGS. 23 and 24 illustrate an expansion device 250 that includes an inner balloon member 252 and a plurality of outer balloon members 254 and that is used in conjunction with a perfusion lumen 256 of an inner tube 258 . Perfusion lumen 256 extends between proximal and distal ends of expansion device 250 . The expansion devices 250 of Figures 23 and 24 are substantially the same, except that the inner balloon member 252 of Figure 24 has a generally peanut or dog-bone shape, as described above with respect to Figures 18A and 18B. It should be appreciated that inflation device 250 may take the form of any inflation device described herein, and lumen 256 may be configured to allow passage of blood between the proximal and distal ends of the inflation device as described in any of the embodiments herein.

In other embodiments, the perfusion channel between the proximal and distal ends of the expansion device may include one or more lumens. For example, as shown in FIGS. 25A and 25B , a perfusion device or catheter assembly 300 includes a tube 302 having a single lumen 304 for blood perfusion between a distal end 308 and a proximal end 306 of an expansion device 310 . Openings 312 in tube 302 allow blood to flow from lumen 304 . Perfusion of blood through lumen 304 may be accomplished in the same or substantially similar manner as described above with respect to FIGS. 20 and 21 .

In another embodiment shown in FIGS. 26A and 26B , a perfusion device or catheter assembly 320 includes a tube or catheter 322 having a plurality of lumens 324 for connecting between a proximal end 326 and a distal end 328 of an expansion device 330 . blood perfusion. One or more openings 332 in tube 322 allow blood to flow outward from one or more lumens 324 . Desirably, tube 322 is formed with at least one aperture 332 in fluid communication with each lumen. Again, perfusion of blood through lumen 324 may be accomplished in the same or substantially similar manner as described above with respect to FIGS. 20 and 21 . However, since there are multiple lumens 324 for blood perfusion, it may be more desirable to include multiple openings 332 that may be aligned with respective openings in the outer rod (not shown).

The above embodiments disclose methods for deploying an expansion device in an orifice or passage of the body. By providing structures that allow and/or increase blood perfusion between the expansion devices, the physician may have additional time to deploy (or deflate) the expansion devices and may reduce the risk of significant side effects due to blood occlusion through the holes or passages.

Additional embodiments for securing a prosthetic device to the distal end of a delivery device are disclosed. Figure 27 illustrates devices and devices for releasably securing a prosthetic device using a release wire. The delivery device 400 includes an inner tube or catheter 402 and an outer tube or catheter 404 (housing). Balloon element 406 and nose cone 408 are located at the distal end of inner tube 402 . The prosthetic device 410 may be secured to the inner tube via one or more strings (eg, wires) 412 extending into respective openings on the prosthetic device 410 . Each string 412 passes through an aperture in the prosthetic device 410 and one or more release wires 414 pass through an aperture or coil 416 at the end of the respective string 412 to secure the prosthetic device 410 to the inner tube. The release wire 414 can be connected to the outer tube 404 and retraction (proximal movement) of the outer tube 404 relative to the inner tube 402 can cause the release wire 414 to be removed from the opening 416 of the string 412, allowing the coil 416 to be pulled through them in the prosthetic device. 410 and thereby release the prosthetic device 410 from the connection formed by the string 412 and the release wire 414 . Optionally, release wire 414 may extend proximally to a handle (not shown) and be moved or released independently of outer tube 404 . In the illustrated embodiment, the prosthetic device 410 comprises a stented prosthetic heart valve. For clarity in the figure, the leaflets of the prosthetic valve are omitted.

In another embodiment shown in FIG. 28 , the delivery device 400 includes a hook element 420 extending from the distal end of the inner tube 402 . The hook elements 420 are preferably biased outwardly so that the distal end of each hook element 420 remains within the aperture 421 in the prosthetic device 410 . To release the prosthetic device 410, the outer tube 404 can be moved distally relative to the inner tube 402 and hook elements, thereby forcing the outwardly deflected hook elements 420 inwardly as the outer tube passes the hook elements. As the outward tube 404 moves past the hook element 420 , the hook element 420 is pressed to the inner diameter of the outer tube, causing the hook element 420 to move radially inward and out of engagement with the opening 421 . Thus, the inward force applied to the hook element 420 by the outer tube 404 releases the prosthetic device 420 from the hook element 420 .

In other embodiments, the prosthetic device may be secured to the delivery device from both ends to provide further operability of the prosthetic valve after it has been expanded. FIG. 29 illustrates schematically (in partial cross-section) a balloon element 450 with a plurality of fixation elements 452 for securing a prosthetic device 454 to the balloon element 450 . The fixation element 452 may include holding flaps extending distally and proximally from the balloon element 450, respectively. The support flaps may be integrally formed with the balloon member 450 or they may be separate members attached (glued, sewn, etc.) to the balloon member 450 . As balloon member 450 deflates, fixation member 452 is pulled away from prosthetic device 454 , thereby releasing prosthetic valve 454 from fixation member 452 .

FIG. 30 illustrates an embodiment in which a prosthetic device (eg, a prosthetic heart valve) is connected to a delivery device 500 at proximal and distal ends. Hook elements 502 (as discussed above) can be used to secure the proximal end of the prosthetic device 504 , while one or more sutures 506 can extend from the proximal end of the delivery device 500 to the distal end of the prosthetic device 504 . For example, suture 506 may extend from the proximal end of delivery device 500 through inner tube 508 and out through opening 505 in nose cone 510 at the distal end of device 500 . Suture 506 may extend from opening 505 and around and around (or through) the distal end of prosthetic device 504 . The sutured free end may then extend back through inner tube 508 to the proximal end of delivery device 500 . Suture 506 may be released from the proximal end of delivery device 500 to release the distal end of prosthetic device 504 .

To maintain tension on the distal end of the prosthetic device 504 , a spring element 512 may be attached to each end of the suture 506 securing the prosthetic device 504 . For example, if 3 sutures 506 are used to secure the distal end of the prosthetic device 504 (as shown in FIG. 27 ), after the suture 506 is looped through the prosthetic device, the 6 ends of the suture 506 can be secured to the proximal end of the delivery device 500. end (eg, at spring element 512).

FIG. 31 illustrates an embodiment in which a prosthetic device (eg, a prosthetic heart valve) is attached to delivery device 600 at both the proximal and distal ends of prosthetic device 604 using sutures. As shown in FIG. 31 , a first set of sutures 602 a can extend from the proximal end of the delivery device 600 through the inner tube 606 and out the opening 609 in the nose cone 610 at the distal end of the delivery device 600 . Similarly, a second set of sutures 602b may extend out of the inner tube 608 and secure the proximal end of the prosthetic device 604 at a region proximal to the prosthetic valve. Sutures 602a and 602b may be attached to prosthetic device 604 in any known manner, including, for example, using the loops discussed above.

The structures and methods described above for hooking or otherwise securing a prosthetic device to a portion of a delivery device may be particularly useful in conjunction with the multi-stage expansion structures described herein. As the prosthetic device is partially inflated, the force exerted on the prosthetic device by the balloon element can be variable and less predictable than under full expansion, so it may be insufficient when the balloon element is inflated to its functional size To hold or grasp the prosthetic valve. Therefore, fixation mechanisms such as those described above may be particularly useful when partially inflating a balloon member or providing a system for expanding a prosthetic valve in stages, since such a fixation structure can keep the prosthetic valve in a fixed position relative to the balloon member. position to ensure predictable and uniform expansion of the prosthetic valve. Moreover, after the prosthetic valve is partially expanded, this fixation structure can maintain the prosthetic valve in a fixed position relative to the delivery device to allow the physician to adjust the prosthetic valve (eg, proximal or distal end) relative to the deployed position in the body lumen. point location.

While many of the embodiments disclosed herein have been described with reference to expanding a prosthetic device, such as a prosthetic heart valve, in a body bore or passageway, it should be understood that the expansion devices and perfusion devices disclosed herein may also be used to perform valvuloplasty procedures . That is, during a valvuloplasty procedure, inflation of the balloon member(s) can be accomplished without the prosthetic device being crimped thereon. The same advantages of blood perfusion described above for the implantation procedure will exist in valvuloplasty procedures that do not include a prosthetic device.

Additionally, it should be understood that the expansion device need not include all of the balloon elements, and may alternatively include a mechanical expansion device. For example, a mechanical expansion element having an open frame configuration may comprise a central expansion element around which a plurality of outer balloon elements are arranged.

32-37 disclose a diagrammatic embodiment of an expansion device (expandable basket) 700 having an open frame configuration. The expansion device 700 may include a plurality of longitudinally extending, circumferentially spaced struts 702 terminating at opposite ends of the expansion device and joined together. For example, as shown in FIG. 32 , strut 702 may extend between distal element (cup) 704 and proximal element (cup) 706 of expansion device 700 . Struts 702 may be formed from various materials and assume various shapes, so long as the shape and structure are strong enough to allow expansion of the prosthetic device, as described in more detail below. For example, each strut 702 may be formed from a tubular structure of a resilient material, such as hard plastic or metal. Additionally, the expansion device 700 can be formed from various numbers of struts 702, so long as the struts are of sufficient number, strength, and/or shape to provide sufficient force to the surface and/or contact points of the prosthetic device to expand the device, as described herein as described.

In operation, distal end 704 and proximal end member 706 are movable relative to each other to expand (by moving closer together) or contract (by moving further apart) expansion device 70 . Relative movement of the distal end 704 and the proximal end element 706 may be achieved by, for example, translating a central screw mechanism 710 extending between and threadedly connected with each element. Referring to Figures 35-37, a method of expanding the expansion device 700 is shown. For convenience, only a single strut 702 is shown in each of these figures. Additionally, the balloon element has been removed in FIGS. 35 and 36 for clarity. FIG. 35 illustrates the mechanical portion of expansion device 700 (ie, strut 702 ) in a collapsed configuration. Figure 36 illustrates strut 702 in an expanded configuration, where the two cups (distal and proximal elements) 704, 706 have been moved closer together, forcing strut 702 to expand radially. Relative movement of the cups 704, 706 may be achieved by, for example, a rotating center screw mechanism 710. Alternatively, the cups 704, 706 can be moved closer together (radially expanding the struts 702) using other structures, such as by pulling or pushing a wire or rod attached to one or both cups 704, 706. ) or further apart (to radially contract struts 702).

FIG. 37 illustrates the strut 702 in a fully expanded configuration with the outer balloon member extending along at least a portion of the surface of the strut 702 . Other struts and outer balloon elements have been removed for clarity. Strut 702 is shown in an expanded configuration, with outer balloon member 708 also expanded. The order of expansion can vary. For example, the inner member (strut 702) can be expanded and then the outer balloon member 708 can be expanded, or alternatively, the outer balloon member 708 can be expanded followed by the inner member (strut 702). Also, as shown in Figure 37, a conduit 711 may extend from the proximal end to the distal end of the expansion device. Fluid delivered through the lumen in catheter 711 can inflate outer balloon member 708 .

A plurality of outer balloon elements 708 may be connected to struts 702 . Each outer balloon member 708 is desirably connected to at least one strut 702 so that it can maintain its position relative to the strut 702 . Plurality of struts 702 may each have an outer surface that defines a support surface for supporting at least one outer balloon member 708 . The width of the support surface of each strut may vary. For example, if only one strut 702 supports each outer balloon member 708, the struts and support surfaces may have a greater width. However, if multiple struts 702 support a single outer balloon member 708, the width of the struts and support surfaces may be smaller. Each of the annular array of struts 702 is laterally deformable to radially expand or radially contract the annular array of struts 702 and the support surfaces they define.

In operation, struts 702 may function similarly to the inner balloon elements disclosed herein. That is, strut 702 has a collapsed configuration (FIG. 32) and an expanded configuration (FIG. 33). Figure 33 illustrates the strut 702 in an expanded configuration, with the outer balloon member maintaining the deflated configuration. When the expansion device 700 is inflated, the bearing surfaces of the struts 702 will push the outer balloon member 708 radially outward toward a prosthetic device (not shown) mounted thereon.

As discussed in other embodiments, the expansion device may be expanded in stages, such as a first stage in which only the struts 702 are expanded (partially expanding the prosthetic device) and a second stage in which the struts 702 and the external balloon Element 708 is expanded (full expansion of the prosthetic device). Additionally, the outer balloon member 708 is preferably expandable independently of the mechanical components of the expansion device 700 (eg, struts). Thus, for example, the outer balloon member 708 may be inflated when the struts 702 of the expansion device 700 are in a collapsed state (FIG. 32) or a fully expanded state (FIG. 33). Because the outer balloon member is independently expandable, the outer balloon member 708 can be inflated either before or after inflation of the strut 702 . That is, as described in other embodiments herein, the order of inflation of the inner member (strut 702 ) and outer member (outer balloon member 708 ) may vary.

The expansion device 700 may be particularly useful in delivering prosthetic heart valves because the mechanical struts 702 provide substantial expansion while at the same time allowing blood to pass around the adjacent outer balloon and through the mostly hollow interior of the expansion device 700 . Referring to FIGS. 36 and 37 , for example, it can be seen that the inner region of the inflation device 700 (ie, the region below the outer balloon member 708 ) is mostly empty space, allowing significant blood perfusion through that portion of the inflation device 700 . Conversely, when the inner member is a balloon member, the inner balloon member occupies most of the inner area of the inflation device and prevents blood perfusion through that portion of the inflation device. Inflation device 700 is also particularly advantageous because it combines the perfusion capabilities of mechanical expansion elements (eg, struts 702 ) with the high pressure inflation strength associated with balloon expansion elements.

38A-38C illustrate a method of deploying a prosthetic heart valve in a native aortic annulus. Referring to Fig. 38A, a delivery device 720 is shown, which delivers a prosthetic heart valve 722 in a collapsed configuration. Delivery device 720 may deliver prosthetic valve 722 to the treatment site using known procedures. For example, prosthetic devices may include the SAPIEN transcatheter heart valve (THV) available from Edwards Lifesciences LLC and the prosthetic valve may be delivered via a transfemoral or transapical approach.

The prosthetic valve 722 may be mounted on an expansion device 724, which may be, for example, an expansion device of the type described herein with reference to FIG. 3 . Prosthetic valve 722 is operable within native arterial annulus 726 to be deployed using delivery device 720 . Referring to FIG. 38B , the expansion device 724 is inflated by expanding the inner balloon member and the outer balloon member of the inflation device 724 . As indicated by arrow B, blood can flow between the proximal end 728 and the distal end 730 of the inflation device 724 through the perfusion path provided by the gap 734 in the inflation device 724, as described and shown herein (e.g., FIG. 4). After the prosthetic device 722 is deployed in the native aortic annulus 726, the expansion device 724 can be deflated (deflated) and removed from the aortic annulus (Fig. 38C).

As discussed above, the number and size of the outer balloon elements (eg, balloon element 52 in FIG. 3 ) can vary. When the expansion device is used for expansion of a prosthetic heart valve (e.g., as shown in FIG. shape. Thus, for example, when expanding a prosthetic heart valve within the annulus of a native arterial valve, it may be desirable to expand the prosthetic heart valve to a generally circular cross-sectional shape.

In general, by increasing the number of outer balloon elements 52, the expansion device can achieve a more rounded outer profile. However, a large number of outer balloon elements 52 will generally result in a smaller gap between adjacent outer balloon elements, which can reduce the total flow area through the inflation device. Accordingly, in some embodiments, the expansion device has an outer balloon member oriented and sized such that the expansion device is capable of expanding the prosthetic heart valve to a generally circular cross-sectional shape while providing a sufficiently large air gap through the expansion device. flow area to allow perfusion of a sufficient volume of blood between the proximal and distal ends of the expansion device.

In some embodiments, when the expansion device is in its expanded configuration, it may be desirable to provide an amount of flow area through the expansion device that is substantially equal to or greater than the effective orifice area (EOA) of the native valve being replaced by the prosthetic heart valve. ). In this way, the same amount of blood perfusion through the native annulus can be achieved in the native annulus using the expansion device in the expanded state as was possible before the expansion device was placed in the native annulus.

As noted above, calcification of the native arterial valve can significantly reduce pore size. 39 is a schematic illustration of a calcified native arterial valve 800 during ventricular systole (eg, in the open state). As can be seen in FIG. 39 , the 3 native leaflets 802 , 804 , 806 cannot fully open due to calcification of the native arterial valve 800 , which results in a decrease in the EOA 808 of the native arterial valve 800 . The EOA of a calcified aortic valve is generally estimated to be between about 0.5 ^cm2 and 0.7 ^cm2 . For example, the EOA of a native arterial annulus with a diameter of about 23 mm, the EOA is estimated to be about 0.56 cm ² and the EOA of a native arterial annulus with a diameter of about 26 mm is estimated to be about 0.65 cm ² .

FIG. 40 illustrates an expansion device 810 similar to the expansion device 28 shown in FIG. 4 . The expansion device 810 has an inner balloon member 812 and seven outer balloon members 814 . A prosthetic heart valve 816 may be mounted on the outer surface of the outer balloon member 814 . As can be seen in Figure 40, the seven outer balloon elements 814 are of sufficient number and size that when the expansion device 810 is inflated, the outer balloon elements 814 compress the prosthetic heart valve 816 and expand it to a generally circular cross-section shape. Gaps 818 are formed between adjacent outer balloon elements 814 to provide a total flow area equal to or exceeding that of the EOA of the calcified native arterial valve 800 shown in FIG. 39 .

Thus, for a 23 mm prosthetic heart valve, the total flow area disposed between outer balloon elements 814 is equal to or greater than about 0.56 cm ² . For a 26 mm prosthetic heart valve, the total flow area disposed between outer balloon elements 814 is equal to or greater than about 0.65 cm ² . For native arterial valves of any size, the total area of the gap at any location along the length of the expansion device 810 is preferably greater than 0.7 ^cm2 to ensure that the flow area equals or exceeds that of the EOA of a calcified native arterial valve. Thus, by providing a total area greater than 0.7 cm ² for blood perfusion, the patient's blood flow conditions will not be deteriorated during delivery of a prosthetic heart valve mounted on expansion device 810 .

Table 1 below illustrates the estimated total flow area achieved by an inflation device with 7 outer balloon elements. It should be understood that the outer diameter of the expansion device corresponds to the size of the prosthetic heart valve expanded by the expansion device.

Table 1

As shown in Table 1 above, the total flow area of the 23 mm and 26 mm prosthetic heart valves can be approximately twice that of the EOA of the calcified aortic annulus (eg, 1.2>2 (0.56) and 1.8>2 (0.65)). Thus, in some embodiments, the total flow area of the expansion device may be greater than about twice the flow area of the EOA of the calcified valve.

For a prosthetic heart valve with a desired expanded size of about 23 mm, the preferred diameter of the inner balloon element is between about 10 and 12 mm (more preferably about 11 mm) and the preferred diameter of the outer balloon element is between about 5 and 7 mm ( More preferably about 6mm). For a prosthetic heart valve with a desired expanded size of about 26 mm, the preferred diameter of the inner balloon element is between about 12 and 14 mm (more preferably about 13 mm) and the preferred diameter of the outer balloon element is between about 5 and 7 mm ( More preferably about 6mm).

Other sizes of expansion devices can be used while still providing the desired flow areas described above. For example, the artificial heart valve can be configured to have a smaller diameter than the 23mm and 26mm artificial heart valves shown in Table 1, such as 20mm, and have a larger diameter than the 23mm and 26mm artificial heart valves shown in Table 1, such as 29mm . For each size of expansion device, the inner and outer balloon members are preferably sized to provide a desired amount of perfusion through the expansion device. For example, in some embodiments, each expansion device can be sized to provide an amount of flow area greater than about 0.7 cm ² and/or an amount of EOA greater than or equal to a calcified valve.

Additionally, in some embodiments, expansion device 810, like the other expansion devices described herein, may be used in a valvuloplasty procedure. In such procedures, the expansion device can be configured to provide an outer diameter that can be used to achieve a desired amount of perfusion through the expansion device during the valvuloplasty procedure. The outer diameter of the expansion device may generally be the same size as the prosthetic heart valves described above. Optionally, in some embodiments it may be desirable to provide an expansion device that expands to an outer diameter that is smaller than those used for expansion of prosthetic heart valves. For example, an expansion device may be provided that expands to an outer diameter of about 16 mm or 17 mm. Of course, such smaller sized expansion devices could also be used to inflate similarly sized prosthetic heart valves, if desired.

FIG. 41 illustrates another embodiment of an expansion device 830 configured to expand a prosthetic heart valve 832 in a native annulus. As in other embodiments described herein, the inner balloon member 834 is surrounded by a plurality of outer balloon members 836 . One or more of the outer balloon elements 836 may include enlarged portions at one or both ends of the installed prosthetic heart valve 832 . For clarity, an expansion device 830 with only two outer balloon elements 836 is illustrated in FIG. 41; however, it should be understood that the number of outer balloon elements may be the same as disclosed in other embodiments, such as that shown in 7 balloon embodiment or the 8 balloon embodiment shown in Figures 5A and 5B.

One or more outer balloon members 836 may have a proximally enlarged portion 838 and a distally enlarged portion 840 . For example, each outer balloon member 836 may have enlarged portions 838,840. Optionally, not all of the outer balloon elements 836 may have enlarged portions 838, 840, as as few as one outer balloon element 836 may have enlarged portions 838, 840, which may help to maintain the prosthetic heart valve 832 in inflated on device 830.

The distance between the proximal and distal enlarged portions 838, 840 may be large enough to accommodate the length of the prosthetic heart valve 832 crimped and/or expanded therebetween. In this way, the outer balloon member can have a peanut-like or dumbbell-like shape, which can help hold the prosthetic heart valve 832 between the two enlarged portions 838, 840 of the generally flat, central portion of the outer balloon member 836. superior. The additional material associated with the enlarged portions 838, 840 can help retain the crimped configuration of the prosthetic heart valve 832 (not shown) on the expansion device 830 when the expansion device 830 is deflated. When the expansion device is fully inflated ( FIG. 41 ), the enlarged portions 838 , 840 are located adjacent the ends of the prosthetic heart valve 832 , thereby limiting movement of the prosthetic heart valve 832 relative to the outer balloon member 836 .

42-44 illustrate another embodiment of an expansion device 850 . The expansion device 850 also includes an inner balloon member 852 and a plurality of outer balloon members 854, as described in other embodiments herein. However, the portion of the outer balloon member 854 that is in contact with the valve has a length BL. The balloon length BL may also be referred to as the "working length" or "working portion" of the balloon because it is the portion of the balloon that contacts and compresses the prosthetic heart valve causing the prosthetic heart valve to expand.

In some embodiments, the working length BL of at least some of the outer balloon elements 854 is shorter than the length VL of the prosthetic heart valve. By reducing the working length BL of the outer balloon member, greater blood perfusion through the inflation device 850 can be achieved. That is, the distance of the gap in the outer balloon element through which blood must flow is shortened, which increases the blood flow rate through inflation device 850 .

Figure 43A is a cross-sectional view taken along the working portion of the outer balloon member 854 (ie, the portion that compresses and expands the prosthetic heart valve). 43B is a cross-sectional view taken along the non-working portion of the outer balloon member 854 (ie, the portion including the reduced-profile tail that does not compress and expand the prosthetic heart valve). A higher blood flow rate through the inflation device 850 can be achieved in the tail region of reduced profile (i.e., the non-working portion of the outer balloon member) because there is more space between adjacent outer balloon members 854 in this region. Large gaps or openings, as shown in Figure 43B.

FIG. 44 illustrates a prosthetic heart valve 856 inflated on a shorter outer balloon member 854 . As described above, blood can more easily travel through the shorter passage provided by the gap between adjacent outer balloon elements 854 , allowing a greater amount of blood to perfuse through inflation device 850 .

FIG. 45 illustrates another embodiment of an expansion device 860 . The expansion device 860 also includes an inner balloon member 862 and a plurality of outer balloon members 864, as described in other embodiments herein. However, the working length BL of at least some of the outer balloon elements 864 is shorter than the length VL of the valve. As described in the previous embodiments, by reducing the working length BL of the outer balloon member, more blood perfusion through the inflation device can be achieved.

In addition to one or more outer balloon elements 864 having a working length BL less than the length VL of a prosthetic heart valve 866 mounted on the expansion device 860, adjacent outer balloon elements 864 may also be longitudinally staggered so that they are not along the length of each other. aligned along the length of the inner balloon member 862. Thus, for example, some of the outer balloon elements 864 may be moved toward the proximal end 867 of the prosthetic heart valve 866 so that they are not placed directly under the distal end 869 of the prosthetic heart valve 866 . The other outer balloon elements 864 are movable towards the distal end 869 of the prosthetic heart valve 866 so that they are not placed directly under the proximal end 867 of the prosthetic heart valve 866 . In some embodiments, the outer balloon members 864 may be alternately staggered, as shown in FIG. .

By providing a staggered and/or alternating arrangement as described above, blood perfusion through inflation device 860 may be increased. Additionally, this staggered arrangement can reduce the collapsed profile of the expansion device 860 because less balloon material is required to produce a balloon with a shorter working length.

FIG. 46 illustrates another embodiment of an expansion device 870 . The expansion device 870 also includes an inner balloon member 872 and a plurality of outer balloon members 874, as described in other embodiments herein. 46 is a cross-sectional view of the expansion device 870 taken along the longitudinal centerline of the expansion device and only two of the plurality of outer balloon members 874 are shown.

Each outer balloon member 874 has a tail 876 extending from either the proximal end or the distal end of each outer balloon member 874 . Tail 876 is preferably attached to a portion of inner balloon member 872 to allow for better control of outer balloon member 874 as it deflates and expands. Thus, for example, tail portion 876 may merge or otherwise connect to inner balloon member 872 at junction point 878 . By attaching the tail 876 as close as possible to the body of the inner balloon member 872, movement of the outer balloon member 874 relative to the inner balloon member 872 can be restricted, which provides a consistent inflation device.

In addition to merging and/or connecting the tail 876 of the outer balloon member 874 to the inner balloon member 872 as shown in FIG. securely connected to further control the movement of the outer balloon member 874 relative to each other and the inner balloon member 872 .

The connection of adjacent outer balloon elements to each other and/or to the inner balloon element may be achieved by bonding the balloon materials together. 47A and 47B illustrate embodiments of linked tails. FIG. 47A illustrates a cross-sectional view of the tail of an expansion device 880 comprising an inner balloon member 882 and a plurality of outer balloon members 884 . Each outer balloon element is secured to an adjacent outer balloon element and to an inner balloon element.

In the embodiment shown in FIG. 47B, instead of simply connecting the tails together, the tails shown in FIG. Lumen 894) integrated expansion device 890. Incorporating the tails in this manner may provide better control of the inflation device by reducing movement between adjacent balloon elements. Additionally, by merging each tail portion together, the diameter of this region of the inflation device can be reduced from a first larger diameter φ1 (FIG. 47A) to a second diameter due to the use of a shared wall portion between adjacent merging balloon elements. Two smaller diameters φ2 (Fig. 47B). Thus, by merging adjacent balloon elements together as described above, not only can the relative movement of the balloon elements be reduced and/or controlled, but the profile of the expansion device can be further reduced.

48A and 48B illustrate one method for merging the tail of the expansion member 890 by pre-shaping the tail of the outer balloon member 894 into a segment or shape that may facilitate merging of the adjacent tail. For example, to facilitate the incorporation process, it may be desirable to pre-shape the tail into a wedge-shaped portion so that each outer balloon element can be incorporated into the outer balloon element adjacent to it, as shown in Figure 48B. The tails can then be joined together by placing the pre-formed tails into a stationary, hot metal mold.

49 , 50A and 50B illustrate another embodiment of an expansion device 900 . The expansion device 900 includes an inner balloon member 902 and a plurality of outer balloon members 904 . Inner balloon member 902 and outer balloon member 904 may be constructed by combining portions of a single balloon. Thus, for example, as shown in FIG. 49 , a single balloon may be pinched and/or merged along multiple lines 906 to provide multiple outer balloon elements 904 .

Because line 906 does not extend the full length of expansion device 900 , a cross-section taken along line 50A- 50A shows only a single lumen 909 at proximal end 908 of expansion device 900 . Similarly, if the cross-section was taken near the distal end 910 of the expansion device 900, it would also show only a single lumen. Between the proximal end 908 and the distal end 910 of the expansion device 900 lumen 909 splits into multiple lumens due to the incorporation of portions of the expansion device 900 along line 906 . The plurality of lumens includes a central lumen defined by inner balloon member 902 and a plurality of lumens defined by outer balloon member 904 . FIG. 50B is a cross-sectional view taken along line 50B- 50B in FIG. 49 showing how cavity 909 is divided into an inner cavity 912 and a plurality of outer cavities 914 . Because all lumens are in fluid communication with each other, when dilation fluid is delivered into lumen 909, the dilation fluid moves into inner lumen 912 and outer lumen 914 simultaneously.

The expansion devices described herein can provide uniform radial expansion of the valve annulus during valvuloplasty procedures and provide uniform radial expansion of prosthetic valves during valve replacement procedures. Furthermore, it should be noted that such expansion devices may be used in stand-alone valvuloplasty procedures, as well as in valvuloplasty procedures performed in preparation for valve replacement surgery. For example, an expansion device may be used to perform a valvuloplasty procedure and then used to expand a prosthetic device in the same annulus. The inflation devices described herein may allow blood to flow through and/or past the inflation device, which may allow the device to be inflated for longer durations and may reduce the need to pace the heart during the process in which the inflation device is inflated in the ring.

The expansion devices described herein can radially expand a prosthetic valve to a generally circular cross-sectional shape by expanding the inner, central expandable element, and one or more outer expandable elements. Conventional multiple balloon inflation devices are not capable of such uniform circular inflation while also providing adequate blood perfusion across the inflatable element. For example, a three-balloon device with 3 balloon elements placed side by side may provide a channel for blood perfusion, but it will expand to a triangular - not circular - shape in cross-section. The expansion devices described herein are capable of expanding into a shape that is generally circular in cross-section while allowing sufficient blood to pass through the device. Additionally, sequential or staged expansion of the expansion devices described herein may allow for generally circular deployment of the prosthetic valve at each stage of deployment.

The methods and devices provided herein also include fixation and stabilization means for securing the prosthetic device during deployment of the prosthetic valve in the native arterial annulus. Because of the substantial pressure that exists in the left ventricle, fixation and stabilization devices as shown in FIGS. 18A-19C and 27-31 can be used to maintain the prosthetic valve in place on the expansion device.

While the Detailed Description of the Invention generally describes deploying a prosthetic valve in the aortic annulus, it should be understood that the expansion devices described herein may be used to expand other prosthetic valves or stents in other areas of the body, including, for example, in the coronary arteries Deliver the bare stent. In addition, the expansion devices described herein may also be used in other medical procedures in which an annulus or channel of the central vasculature is to be enlarged, with or without deployment of a stent or other prosthetic element. For example, expansion devices described herein may be used in angioplasty procedures, including, for example, coronary artery dilation procedures. However, for the reasons discussed above, the expansion devices described herein are particularly advantageous in valvuloplasty and replacement valve procedures.

In view of the many possible embodiments to which the principles disclosed herein may be applied, it should be recognized that the illustrated embodiments are only preferred examples of the invention and should not be taken as limiting the scope of the invention. Rather, the scope of the invention is defined by the appended claims. We therefore claim that our inventions are all inventions within the scope and spirit of these claims.

Claims (21)

1. A system for delivering an expansion device to a treatment site in a patient, said system comprising: an elongated rod having a distal end; and an expansion device connected to said distal portion of said elongated rod and movable between a collapsed configuration and an expanded configuration, said expansion device having a distal end and a proximal end, and said expansion device comprising an inner expandable element and a plurality of outer expandable elements, each portion of which is movable relative to said inner expandable element, wherein said plurality of outer expandable elements comprises at least 5 outer expandable elements at least partially surrounding said inner expandable element and when said expansion device is in said expanded configuration, a gap between adjacent outer expandable elements The void provides a perfusion channel through the expansion device. 2. The system of claim 1, wherein the outer expandable element forms a generally circular outer profile when the expansion device is in the expanded configuration. 3. The system of claim 1, wherein the inner expandable element is expandable independently of the plurality of outer expandable elements. 4. The system of claim 1, wherein one or more of the plurality of external expandable elements is expandable independently of other of the plurality of external expandable elements. 5. The system of claim 1, wherein the plurality of outer expandable elements are not fixed relative to an outer surface of the inner expandable element at a region between a proximal end and a distal end of the inner expandable element. 6. The system of claim 1, wherein the plurality of outer expandable elements are affixed to proximal and distal ends of the inner expandable element. 7. The system of claim 6, wherein the plurality of outer expandable elements are incorporated into the inner expandable element at proximal and distal ends of the inner expandable element. 8. The system of claim 1, wherein each outer expandable element includes a distal end and a proximal end, and the distal end and the proximal end of at least one outer expandable element include enlarged portions, the at least one outer The expandable member is configured to receive a prosthetic device between the enlarged portion at the distal end and the enlarged portion at the proximal end. 9. The system of claim 1, further comprising a prosthetic device in a crimped configuration, the outer expandable member comprising an outer surface configured to receive the prosthetic device. 10. The system of claim 9, wherein the prosthetic device comprises a valve having a plurality of leaflets forming a plurality of commissures, and the outer expandable element is connected to the plurality of leaflets of the prosthetic device. One or more spaced apart orientations of the commissures, the valve is configured to be received on an outer surface of the outer expandable member. 11. The system of claim 1, wherein the inner expandable element has a distal end, a proximal end, and an intermediate portion between the distal end and the proximal end, and when the inner expandable element is in an expanded configuration , the diameter of the middle portion is smaller than the diameter of the distal portion. 12. The system of claim 1, wherein the inner expandable member and the outer expandable member comprise balloon members. 13. The system of claim 12, wherein the plurality of outer expandable elements comprises seven balloon elements. 14. The system of claim 13, wherein the inner expandable member has a diameter of 10-12 mm and the balloon member has a diameter of 5-7 mm. 15. The system of claim 13, wherein the inner expandable member has a diameter of 12-14 mm and the balloon member has a diameter of 5-7 mm. 16. An expansion device comprising: an elongated rod having a distal end; an inner balloon member connected to said distal end of said elongated shaft and movable between a collapsed configuration and an expanded configuration; and a plurality of outer balloon members at least partially surrounding the inner balloon member, each of the outer balloon members being movable between a collapsed configuration and an expanded configuration, the outer balloon members when in the expanded configuration having a generally circular cross-sectional shape, a portion of each outer balloon member being movable relative to said inner balloon member, wherein, when said inner balloon member and at least some of said outer balloon members are in said expanded configuration within a body lumen, a plurality of channels are disposed between an outer surface of the inflated inner balloon member and an inner surface of the body lumen, to allow blood to flow through the channel and through the inflation device. 17. The expansion device of claim 16 , wherein the outer balloon member includes an outer surface configured to contact and compress a prosthetic heart valve when in the expanded configuration to expand the prosthetic heart valve to substantially Circular cross-sectional shape. 18. The expansion device of claim 17, wherein each outer balloon member has a working length that includes a portion of the outer balloon member that contacts and compresses the prosthetic heart valve, and at least some of the outer balloon members The working length is shorter than the length of the prosthetic heart valve. 19. The expansion device of claim 18, wherein the outer balloon members are staggered such that at least some of the outer balloon members are not aligned along the length of the inner balloon member. 20. The expansion device of claim 16, wherein the plurality of outer balloon members are secured to an outer surface of the inner balloon member at proximal and distal ends of the inner balloon member. 21. The expansion device of claim 16, wherein the channel has a total cross-sectional area at any location along the length of the inner balloon member equal to or greater than 0.7 ^cm2 .